1. Field of the Invention
The present invention relates to an assembly for collection of a biological sample. More particularly, the present invention relates to a sample collection assembly which permits the simultaneous collection of a bulk sample and a drop sample and which provides for coordinated tracking and identification of the sample.
2. Description of Related Art
Various biological samples, such as whole blood, urine specimen, saliva and fecal samples are commonly collected in containers and tubes for subsequent testing and analysis. Each type of sample uses a distinct collection container and associated sampling techniques. For example, with respect to the collection of blood, samples of whole blood are typically collected from a patient by venipuncture with a cannula or a needle attached to a syringe or an evacuated collection tube. A container such as a blood collection tube containing the collected sample is subsequently shipped to a laboratory where experienced personnel subject the blood sample to specific tests.
Often, it is necessary for a small amount of the collected sample to be tested separately from the bulk of the collected sample. Such tests may include PCR (polymerase chain reaction) or other gene amplification analyses. These tests are typically conducted on a drop sample, that is, a drop of the sample fluid placed on filter paper or other substrate. The drop sample may be placed on the filter paper either at the time of sample collection from the patient or subsequently from the previously obtained bulk sample. In either case, an additional step of collecting the drop sample is required. Where the drop sample is obtained directly from the patient, it requires the technician to obtain the drop sample separate from the bulk sample and also to assure that the drop sample is separately identified, ID contained and transported in a safe and efficient manner along with the coordinated identification and transport of the bulk sample. Where the drop sample is obtained from the bulk sample at the laboratory, it requires the technician to reenter the bulk specimen container to obtain the drop sample.
In both instances, the potential exists for mishandling or misidentifying the drop sample with respect to the bulk sample. Furthermore, obtaining a drop sample separately from the bulk sample also potentially poses an increased biohazard risk to the technician collecting and transporting the separate samples.
It is therefore desirable to provide a technique for obtaining a drop sample simultaneously with a bulk sample and to assure proper identification and trackability between the bulk sample and the drop sample during transport and analysis.
The present invention provides a sample collection assembly for the collection of a drop sample and a bulk sample. The collection assembly includes a sample collection container having an opening and a drop sample substrate positioned across the opening and capable of being puncturable by a probe. The substrate includes a drop sample retaining surface facing the container interior for retaining a drop sample upon withdrawal of the probe from the container.
The container preferably includes an interior and exterior surface. The drop sample substrate is in the shape of an elongate strip having a first portion attached to the exterior surface of the container and a second portion positioned across the opening of the container. The second portion of the elongate strip is removable from the first portion by way of a perforation therebetween.
The interior surface of the drop sample substrate may include a specimen retaining filter paper for containing the specimen upon withdrawal of the probe.
The drop sample substrate may further include a specimen impervious liner surface opposite the sample retaining surface. The liner surface helps prevent fluid leakage therethrough.
The elongate strip may include indicia bearing locations in both the first and second portions. These indicia bearing locations provide coordinated identification of the bulk sample and the drop sample where the drop sample is transported separately from the bulk sample.
The container may be covered by a container closure over the opening, whereby the drop sample substrate is positionable over the closure.
The present invention may be used to collect a bulk specimen which is defined to be a quantity of a certain biological specimen such as blood, urine, saliva, sputum or fecal samples larger than a few drops. The present invention further provides for collection of a drop sample which is defined to be a small quantity, such as a single drop, on a substrate simultaneously with the collection of the bulk sample.
The present invention provides a sample collection assembly for creating a drop sample simultaneously with collection of a bulk sample. The present invention further provides for identification of the bulk sample and the drop sample for permitting coordinated tracking of the bulk sample and drop sample during transportation and testing.
The assembly of the present invention provides the means to separate and trap formed elements such as cells, virus, platelets and bacteria from the fluid portion of a biological sample, thus eliminating sample preparation steps such as centrifugation, filtration or precipitation.
Another attribute of the assembly of the present invention is that it provides for transport of a non-liquid sample as well as provides a stable sample for laboratory analysis.